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Trial registered on ANZCTR


Registration number
ACTRN12609000222246
Ethics application status
Approved
Date submitted
8/04/2009
Date registered
1/05/2009
Date last updated
5/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Observational study monitoring the effects of oral cabergoline on avoidance of symptoms of Ovarian Hyperstimulation Syndrome (OHSS) in patients at risk of ovarian hyperstimulation syndrome when undergoing an In-Vitro Fertilisation (IVF) cycle
Scientific title
An observational study monitoring the effects of oral cabergoline on avoidance of symptoms of Ovarian Hyperstimulation Syndrome (OHSS) in patients at risk of ovarian hyperstimulation syndrome when undergoing an In-Vitro Fertilisation (IVF) cycle.
Secondary ID [1] 262891 0
CABERGOLINE FOR OHSS
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian hyperstimulation syndrome (OHSS) 4576 0
Condition category
Condition code
Reproductive Health and Childbirth 4870 4870 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In an IVF cycle oral cabergoline tablets 0.5mg per day will be taken from the day of initiation of follicular maturation by the sub-cutaneous injection of human chorionic gonadotrophin (HCG) prior to egg collection for a total of seven days. Despite egg collection and their fertilisation by their partner's sperm, embryos will be frozen and no fresh embryo transfer will be performed as these patients are at risk of OHSS. This is a 3 year observational study of all patients at risk of OHSS. Patients will only take the cabergoline as described if they are considered at risk of OHSS during their IVF cycle.
Intervention code [1] 4339 0
Not applicable
Comparator / control treatment
Comparison will be our historical data (2006-2009) of hospital admission for OHSS.
Control group
Historical

Outcomes
Primary outcome [1] 5722 0
OHSS. This is an internationally defined medical condition based on patient's symptoms and clinical tests; ultrasound examination and blood tests.
Timepoint [1] 5722 0
Every patient in every IVF cycle is observed closely for the symptoms of OHSS after their egg collection and prior to the onset of menstruation (usually approximately 14 days). They will be in daily contact with the IVF unit in case of any emergency and they will be asked about any symptoms on a regular basis during the study, at the discontinuation of cabergoline and at the end of onset of menstruation.
Secondary outcome [1] 241656 0
Side-effects or adverse outcomes. None are anticipated from the previous reported Randomised Controlled Trails (RTCs) and cabergoline is regularly used in gynaecological practice. The side-effects will be determined by verbally asking the patients and if required appropriate clinical tests will be performed.
Timepoint [1] 241656 0
OHSS is a rare consequence of IVF occurring in approximately 1-3% of IVF cycles. Our unit undertakes roughly 400 cycles per year and it is therefore envisaged that approximately 4-12 patients per year will be recruited. They will be given cabergoline for seven days from the time of HCG injection. This observational study will run for 3 years and will include all patients at risk of OHSS administered with cabergoline. They will all be asked about any side-effects from the treatment during the course of this seven day time period on a regular basis and at the end of the 7 day period

Eligibility
Key inclusion criteria
Patients whose oestradiol level is >15,000 pmol/l, or more than 20 follicles on ultrasound examination prior to the day of HCG trigger
Minimum age
20 Years
Maximum age
45 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients with a significant concurrent medical illness or a contraindication to the administration of cabergoline.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4763 0
Self funded/Unfunded
Name [1] 4763 0
Address [1] 4763 0
Country [1] 4763 0
Primary sponsor type
Commercial sector/Industry
Name
Fertility Specialists of Western Australia
Address
Bethesda Hospital, 25 Queenslea Drive, Claremont WA 6010
Country
Australia
Secondary sponsor category [1] 4301 0
University
Name [1] 4301 0
School of Women's and Infants Health, University of Western Australia (UWA)
Address [1] 4301 0
King Edward Memorial Hospital, 374 Bagot Road, Subiaco WA 6008
Country [1] 4301 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6810 0
Curtin University of Technology
Ethics committee address [1] 6810 0
GPO Box U1987, Perth WA 6845
Ethics committee country [1] 6810 0
Australia
Date submitted for ethics approval [1] 6810 0
Approval date [1] 6810 0
20/11/2008
Ethics approval number [1] 6810 0
HR 147/2008

Summary
Brief summary
2 randomised controlled trials have demonstrated the safety and efficacy of cabergoline to limit the development of ovarian hyperstimulation syndrome (OHSS) in women at risk of this condition undergoing IVF treatment. This prospective observational study aims to look at the incidence of the development of the condition and any side-effects caused by the administration of cabergoline by women at risk of OHSS.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29474 0
Address 29474 0
Country 29474 0
Phone 29474 0
Fax 29474 0
Email 29474 0
Contact person for public queries
Name 12721 0
Professor Roger Hart
Address 12721 0
Fertility Specialists of Western Australia
Bethesda Hospital, 25 Queenslea Drive, Claremont WA 6010
Country 12721 0
Australia
Phone 12721 0
+61 8 93406419
Fax 12721 0
Email 12721 0
info@fertilitywa.com.au
Contact person for scientific queries
Name 3649 0
Professor Roger Hart
Address 3649 0
Fertility Specialists of Western Australia
Bethesda Hospital, 25 Queenslea Drive, Claremont WA 6010
Country 3649 0
Australia
Phone 3649 0
+61 8 93406419
Fax 3649 0
Email 3649 0
rogerhart@fertilitywa.com.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary